It’s been all over the news. Pfizer is seeking to do what the magicians at Merck failed to conjure up with Mevacor, get an over-the-counter (OTC) approval for their statin Lipitor.

NEWS FLASH: THEY ARE NOT DOING THIS TO BENEFIT SOCIETY (I know, a complete shocker to you all).

Big Pharma only bellies back up to the FDA bar when a patent is running dry and profits are expected to dwindle when generic manufacturers start entering the game with a cheaper version. Going OTC is a way to wring more profit from a drug as all you have to do is convince the public that the brand name is better, not the gate keepers of a formulary. And snazzy advertising sways a lot of people (you know what the Purple Pill is, don’t you?).

OTC can be good. The best example is antihistamines. In Canada by 1995 the newer antihistamines, like cetirizine (Zyrtec), were available OTC. Why? Because these drugs have few, if any, dangerous side effects. There is also no significant overdose potential or medication interactions. Seasonal allergies are also not conditions that require close medical supervision. In Canada the patent didn’t have to run out for antihistamines, they simply went OTC, but then again prescription drugs are much cheaper in Canada, so there is less benefit to requiring a prescription.

It makes perfect sense to have a safe medication for a non-serious condition that is pretty easy to self-diagnose available OTC.

However in the US, where Big Pharma runs things, a drug makes more money when it is prescription because Pharma can charge outrageous prices that are sucked up by health insurance. We see the $25 or $50 co-pay upfront, but we really pay for it with rising premiums. Of course, for those who don’t have insurance the drug is unaffordable. When a drug goes OTC the cost is no longer partly absorbed by insurance, so it actually becomes more expensive for the insured and of course still out of reach for most without insurance.

Guess when cetirizine went OTC in the US? 2007, after the patent expired of course.

If I were Supreme Empress of the FDA (which I’m not except in some conversations that happen entirely in my head) I would laugh at Pfizer and any other asshat company bringing an OTC application that temporally matches the patent’s expiration date.

If I were Supreme Empress of the FDA I would only accept OTC applications within 2 years of the drug going to market. Get the post marketing surveillance in and then if it’s as safe as expected, have at your OTC application. I mean, you still have the patent so no generic can compete.

High cholesterol is not like seasonal allergies. It can (and does) kill people. It requires, you know, medical supervision. Tests and things. Maybe some blood pressure monitoring, asking a family history, the kind of silly stuff we learn in medical school.

Statins also have side effects and serious drug interactions. You know, the kinds of things doctors and pharmacists discuss with their patients.

And finally, for most patients with insurance the price of Lipitor would actually go up if it were to become OTC so fewer people might take it.

Allowing a company to play it both ways is just wrong. A drug is either safe and ready to go OTC essentially from day 1 (like cetirizine/Zyrtec) or it’s not. Medications don’t get safer with time.

The FDA shouldn’t give a rat’s ass if the patent on Lipitor, or any other drug for that matter, is expiring or not. They shouldn’t even accept these kinds of applications. Unless of course, they exist to serve Big Pharma and not, you know, the people.

Discussion

You said it! Here in the UK we were ‘priviledged’ to have simvastatin reclassified as OTC with, I might add, great fan fare. Has been a number of years now, and you would be hard pressed to find any pharmacy with stock of simvastatin on its shelves. It just does not work, and here is why:
1. Pharmacies do not have the means of doing a fasting cholesterol test, and a total cholesterol test is not enougth evidence to initiate thearapy. Once we had done the total cholesterol test, and the results were out of range, all we could do was refer the patient to the surgery, where the proper diagnosis was done, and hey presto, treatment also started. So in essence all we did was act as a screening agency for the surgeries.
2. Most patients that required treatment, were 60 years and older, and therefor choose to get their meds prescribed and on the NHS rather than pay for it at the pharmacy.
3. Only the 10mg strength was made available OTC, which has limited scope.

It has now been years since, and the only use I have found for OTC simvastatin is to offer it for sale late Saturday afternoons, when patients come running in saying that they had run out of their meds and the surgeries are closed. Not that skipping a dose or two will cause any harm.

All in all, reclassifying a statin OTC is a monumental waste of time and effort. Coupled with the concerns you have highlighted about interactions, etc. I truely believe that it is actually more irresponsible than a so called ‘benefit to the patient’. It is all about money, is it not?

Thanks for a great blog and for highlighting these issues, allowing true debate.
DrugMagister

For the most part, antihistamines are safe. Having said that, antihistamines can have side effects which, if the antihistamine is not properly administered, can be serious. The truth is, all medications have side effects. Some are mild, as in the case of an aspirin, unless you have stomach ulcers or aspirin sensitivity and others are more serious such as the side effects from chemotherapy, but for the most part, antihistamine side effects are fairly mild. The newest antihistamines are probably about the safest medications that there are. But there are differences between the various antihistamines and their side effects.*